Health product recall

ACUSON SC2000 PRIME Ultrasound System - Mainframe (2018-01-31)

Starting date:
January 31, 2018
Posting date:
February 16, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66006

Affected products

ACUSON SC2000 PRIME Ultrasound System - Mainframe

Reason

Siemens is notifying users of a potential issue with the ACUSON SC2000 ultrasound system with software versions VB10A, VB10B, VB10D and VB10E. The 3D eSie PISA volume analysis application quantifies valvular regurgitation. While imaging with the Z6Ms volume transesophageal echocardiography transducer, this application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.

Affected products

ACUSON SC2000 PRIME Ultrasound System - Mainframe

Lot or serial number

All lots.

Model or catalog number

10433816

Companies
Manufacturer
Siemens Medical Solutions USA, Inc.
685 Middlefield Road
Mountain View
94043
California
UNITED STATES